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Excess Mortality Rate Associated with Hepatitis C Virus Infection: a Community-Based Cohort Study in Rural Egypt

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Excess Mortality Rate Associated with Hepatitis C Virus Infection: a Community-Based Cohort Study in Rural Egypt Research Article Excess mortality rate associated with hepatitis C virus infection: A community-based cohort study in rural Egypt Aya Mostafa1,y, Yusuke Shimakawa2,y, Ahmed Medhat3, Nabiel N. Mikhail4, Cédric B. Chesnais2,5, Naglaa Arafa1, Iman Bakr1, Mostafa El Hoseiny1, Mai El-Daly6,7, Gamal Esmat8, ⇑ Mohamed Abdel-Hamid6,9, Mostafa K. Mohamed1, Arnaud Fontanet2,10, 1Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 2Unité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France; 3Department of Gastroenterology & Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt; 4Department of Biostatistics and Cancer Epidemiology, South Egypt Cancer Institute, Assiut University, Assiut, Egypt; 5UMI 233, Institut de Recherche pour le Développement (IRD), Montpellier, France; 6Viral Hepatitis Research Laboratory, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; 7National Liver Institute, Menoufia University, Menoufia, Egypt; 8Endemic Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt; 9Department of Microbiology and Immunology, Faculty of Medicine, Minia University, Minia, Egypt; 10Département d’Infection et Épidémiologie, Conservatoire National des Arts et Métiers, Paris, France Background & Aims: >80% of people chronically infected with Conclusions: Use of a highly potent new antiviral agent to treat hepatitis C virus (HCV) live in resource-limited countries, yet all villagers with positive HCV RNA may reduce all-cause mortal- the excess mortality associated with HCV infection in these set- ity rate by up to 5% and hepatic mortality by up to 40% in rural tings is poorly documented. Egypt. Methods: Individuals were recruited from three villages in rural Ó 2016 European Association for the Study of the Liver. Published Egypt in 1997–2003 and their vital status was determined in by Elsevier B.V. All rights reserved. 2008–2009. Mortality rates across the cohorts were compared according to HCV status: chronic HCV infection (anti-HCV anti- body positive and HCV RNA positive), cleared HCV infection Introduction (anti-HCV antibody positive and HCV RNA negative) and never infected (anti-HCV antibody negative). Data related to cause of Hepatitis C virus (HCV) infection is an important public health death was collected from a death registry in one village. issue. Globally, 115 million people have been infected with Results: Among 18,111 survey participants enrolled in 1997– HCV, of whom 80 million are chronically infected [1]. Each year, 2003, 9.1% had chronic HCV infection, 5.5% had cleared HCV an estimated 700,000 people die from HCV, mainly through liver infection, and 85.4% had never been infected. After a mean time cirrhosis and/or hepatocellular carcinoma (HCC) [2]. The majority to follow-up of 8.6 years, vital status was obtained for 16,282 (>80%) of people chronically infected with HCV reside in low- and (89.9%) participants. When compared to those who had never middle-income countries [1], and Egypt has the highest preva- been infected with HCV in the same age groups, mortality rate lence of chronic HCV infection, estimated at 10.0% in adults [3]. ratios (MRR) of males with chronic HCV infection aged <35, With the recent advent of new antiviral therapy which is 35–44, and 45–54 years were 2.35 (95% CI 1.00–5.49), 2.87 expected to cure more than 90% of chronic infection within a (1.46–5.63), and 2.22 (1.29–3.81), respectively. No difference in short duration [4], Egypt has started treating a large number of mortality rate was seen in older males or in females. The infected persons through 23 national treatment centres with a all-cause mortality rate attributable to chronic HCV infection regimen that includes the new antiviral agent sofosbuvir [5].To was 5.7% (95% CI: 1.0–10.1%), while liver-related mortality was assess the population impact of this national treatment pro- 45.5% (11.3–66.4%). gramme, it is critical to understand the natural history of chronic HCV infection and the excess mortality associated with chronic HCV infection in the local context before treatment programmes Keywords: Hepatitis C; Mortality; Cohort studies; Egypt; Africa. are implemented. Received 6 October 2015; received in revised form 12 February 2016; accepted 16 Several cohort studies have examined the impact of HCV February 2016; available online 26 February 2016 infection on all-cause and cause-specific mortality rates in ⇑ Corresponding author. Address: Unité d’Épidémiologie des Maladies Émergen- general population [6–16]. However, these studies have been tes, Institut Pasteur, 25 rue du Docteur Roux, Paris, France. Tel.: +33 1 4061 3763; fax: +33 1 4568 8876. restricted to high income countries. To date there has been no E-mail address: [email protected] (A. Fontanet). similar study conducted in middle- and low-income countries. y These authors have contributed equally as joint first authors. Moreover, the estimates from studies conducted in high income Abbreviations: HCV, Hepatitis C Virus; HCC, Hepatocellular carcinoma; HIV, countries have limited generalisability to other settings. For Human Immunodeficiency Virus; HBV, Hepatitis B Virus; RNA, Ribonucleic acid; example, among people with chronic HCV infection, those who PAF, Population attributable fraction; MRR, Mortality rate ratios; PY, Person- years; 95% CI, 95% confidence interval; IQR, Interquartile range. inject drugs – a major route of HCV transmission in Europe and Journal of Hepatology 2016 vol. 64 j 1240–1246 JOURNAL OF HEPATOLOGY North America – are thought to have additional causes of of death was classified into one of eight categories: liver-related (including increased mortality, such as drug overdose, excessive alcohol HCC), neoplasms (excluding HCC), stroke, heart disease, pulmonary disease, kid- ney disease, other and unknown causes [11]. intake, and co-infection with HIV or hepatitis B virus (HBV) [7–9,13,14]. In contrast, in resource-limited countries, iatrogenic Statistical analyses procedures are the most frequent mode of HCV transmission [17]. In Egypt, the beginning of the HCV epidemic has been asso- HCV status at enrolment was treated as a categorical variable (chronically ciated with the mass parenteral anti-schistosomal treatment infected, cleared HCV infection and never infected). Baseline characteristics of campaigns in the 1960s–70s [18], and has since spread through participants were compared according to each HCV status using Chi-square test the reuse of medical devices [19]. As a result, in a generalized for categorical variables and Kruskal-Wallis one-way analysis of variance for con- epidemic, such as the one of Egypt, it is expected that the risk tinuous variables. The person-years of follow-up were calculated from the date the participants were enrolled in the study to the date of death, migration, or last of mortality among HCV-infected in Egypt will be different to that follow-up, whichever came first. The association between HCV status and all- found in high income countries. cause mortality was examined by estimating mortality rate ratios (MRR) using We therefore conducted a community-based cohort study in Poisson regression, and adjusted for potential confounding variables: sex, current rural Egypt to estimate the all-cause mortality rates according age, study village, education (ever or never attended school: a proxy for socio- to HCV status: chronic HCV infection (anti-HCV antibody positive economic status), and comorbidity. Comorbidity was defined as the presence of any of the following medical history at enrolment: P2 episodes of blood transfu- and HCV RNA positive), cleared HCV infection (anti-HCV antibody sion, P2 hospital admissions, P2 surgical procedures or undertaking dialysis. As positive and HCV RNA negative) and never infected (anti-HCV HCV-related mortality risk is known to be higher in males compared to females antibody negative). In addition, we estimated the fraction of and in older persons compared to other age groups [8], the interactions between all-cause and liver-related mortality rates attributable to chronic sex and chronic HCV infection, and between age and chronic HCV infection, on mortality were examined using a likelihood ratio test by adding interaction terms HCV infection (population attributable fraction: PAF). in a Poisson regression model adjusted for other confounders (study village, edu- cation and comorbidity). The cohort in Zawiat Razin was used to describe the cause of death, and the association between HCV status and liver-related mortal- ity. Finally, the PAF and its 95% confidence interval (95% CI) were estimated for Patients and methods the effect of chronic HCV infection on all-cause mortality rate (across all three vil- lages) and on liver-related mortality rate (in Zawiat Razin). The ‘‘punaf” STATA Baseline sero-surveys command was used after fitting a Poisson regression model that included poten- tial confounders and the effect modifiers [29]. All analyses were performed using Community-based sero-surveys for HCV infection were conducted in three rural STATA 13.0 (Stata Corporation, College Station, TX). villages in Egypt. In Sallam, Upper Egypt, all villagers aged P5 years were invited to participate in the sero-survey between 1997–1999 [20–22]. In two villages in the Nile Delta, Aghour El Soughra [22–24] and Zawiat Razin [19,25,26], randomly Results selected inhabitants aged P5 years were invited to the surveys between 1997– 1999 and 2002–2003, respectively. After written informed consent was provided, Baseline characteristics participants underwent a standardised clinical examination, a blood sample was collected, and a structured interview that assessed socio-demographic status and potential risk factors for HCV transmission was conducted. Participants identified A total of 18,111 inhabitants participated in the baseline sero- as having a chronic HCV infection were referred to a hepatology clinic for further surveys (4,311 in Aghour El Soughra, 7,385 in Sallam and 6,415 clinical management, and those eligible and willing to be treated were offered in Zawiat Razin) in 1997–2003. Survey uptake was 62.8%, 75.4% pegylated interferon (PegIFN) and ribavirin [27].
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